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Exercise, Glucose Kinetics, and the Incretin Effect

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01607931
First received: May 23, 2012
Last updated: December 22, 2012
Last verified: December 2012

May 23, 2012
December 22, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
  • Glucose tolerance [ Time Frame: Plasma glucose will be measured at 10 minute intervals during the OGTT (3 hours) immediately following the period of rest or exercise ] [ Designated as safety issue: No ]
  • Incretin effect [ Time Frame: Plasma insulin and C-peptide will be measured at 10 minute intervals during the OGTT (3 hours) and isoglycemic clamp (3 hours) immediately following the period of rest or exercise ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01607931 on ClinicalTrials.gov Archive Site
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Exercise, Glucose Kinetics, and the Incretin Effect
The Effects of Acute Exercise on Glucose Kinetics, Beta-cell Function and the Incretin Effect in Subjects Representative of the Whole Glucose Tolerance Continuum

Human volunteers will be stratified by oral glucose tolerance status: normal glucose tolerant, impaired glucose tolerant, and type 2 diabetic. All subjects will undergo 4 experimental trials: [1] an oral glucose tolerance test (OGTT) combined with infused and ingested stable isotopes of glucose to assess glucose kinetics. [2] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by the same OGTT combined with stable isotope glucose tracers used in trial 1. [3] an isoglycemic clamp to match the plasma glucose profile measured in trial 1. [4] a 1 hour bout of cycling exercise at 50% of maximum power output, immediately followed by an isoglycemic clamp to match the plasma glucose profile measured in trial 2.

Exercise-induced changes in oral glucose tolerance, glucose kinetics, insulin and glucagon secretion, and the incretin effect will be examined. The exercise responses will be compared between the subjects groups of different glucose tolerance status.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes
Behavioral: Exercise
1 hour of cycling at 50% of maximum power output
  • No Intervention: Resting Trial
    a 1 hour period of rest immediately prior to OGTT or isoglycemic clamp
  • Experimental: Exercise Trial
    a 1 hour cycling exercise bout immediately prior to the OGTT or isoglycemic clamp
    Intervention: Behavioral: Exercise
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
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December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-60 years
  • BMI 18-35 kg/m2

Exclusion Criteria:

  • insulin dependency
  • pregnancy
  • presence or history of chronic cardiovascular, pulmonary, hepatic, renal, or hematological disease, or cancer
  • contraindication to physical activity as assessed by ECG
Both
18 Years to 60 Years
Yes
Contact: Thomas P Solomon, PhD thomas.solomon@inflammation-metabolism.dk
Contact: Sine H Knudsen, MSc sine_haugaard_2@hotmail.com
Denmark
 
NCT01607931
EFSD-2012
No
Thomas Solomon, Rigshospitalet, Denmark
Rigshospitalet, Denmark
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Not Provided
Rigshospitalet, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP